This portion of the UDI is both specific to the manufacturer and device-group. This is the “access-key” to the UDI database information.
This shall identify the unit of device production and may include the serial number, the lot number, software identification and manufacturing / expiry date. This tracks the specific production series.
(2) Health Industry Business Communications Council (HIBCC);
(3) ICCBBA; and
(4) Informationsstelle für Arzneispezialitäten — IFA GmbH.
|Class III / Implantable||Class IIa / IIb||Class I|
|Placing UDI-carrier on device labels||26 May 2021||26 May 2023||26 May 2025|
|Direct marking of reusable medical devices||26 May 2023||26 May 2025||26 May 2027|
|IVDR Requirement||Class D||Class C and B||Class A|
|Placing UDI-carrier on device labels||26 May 2023||26 May 2025||26 May 2027|